Functional Area: Drug Safety and Pharmacovigilance
1)Perform triage, completeness, legibility and validity of incoming adverse event case reports (Serious and Non-serious events) originated from clinical and post marketing studies.
2)Assess case reports for seriousness, causality, expectedness and validity of incoming safety information.
3)Ensure an accurate and timely reporting of expedited safety reports to DCGI and applicable Regulatory Authority.
4)Timely follow up with Investigator and other health care professionals for outstanding information.
5) Perform data entry, narrative writing, report scheduling in client owned databases.
6) Coordinate with data management, clinical team and investigational sites for SAE queries reconciliation.
7) Written SAE management plan, SOPs and timely update country specific safety reporting requirement.
8) Get actively involved in discussions, study training meetings for Safety.
9) To Manage queries and discrepancies from Sponsor, IEC/IRB and Regulatory Authority.
10) Provides mentorship to existing and new staff within the department with regard to AE/SAE reporting process and regulatory reporting requirements.
Salary: INR 4,00,000 - 6,00,000 P.A.
Employment Type:Permanent Job, Full Time
Desired Candidate Profile
UG:B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy
Pharma Placements Inc.
Recruiter Name:Pharma Placements Team
Contact Company:Pharma Placements Inc.
Address :F 99, First Floor, B Wing, Express Zone Mall, Opp. Adani Energy, W.E.Highway, Goregaon (E), Mumbai